Marketing authorisations

• Medicinal Products Act

• Minister of Social Affairs Regulation No. 13 of 26 February 2010 “Types of variations to conditions which constitute basis for grant of marketing authorisation, and conditions and procedure for application for variations“

• Minister of Social Affairs Regulation No. 26 of 16 July 2010 “Procedure for providing safety information about a medicinal product and the calculation of fee payable for safety and quality surveillance of a medicinal product"

• Minister of Social Affairs Regulation No. 28 of 18 February 2005 „Types of and Formal Requirements for Applications for Marketing Authorisation of Medicinal Products, a List of Supplementary Documentation, Requirements for Supplementary Documentation, Amount of Remuneration Payable for Professional Assessment of Applications Set out by Types of Application, and the Procedure for Calculation and Payment of Remuneration“

• Minister of Social Affairs Regulation No. 29 of 18 February 2005 „Terms and procedure for granting and renewing of a marketing authorisation of a medicinal product and handling of an application, and recognising of the evaluation of a competent institution of a member state of the European Economic Area“

• Minister of Social Affairs Regulation No. 59 of 13 April 2005 „The Conditions and Procedure for Classifying a Substance or Product as a Medicinal Product“

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